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A CLINICAL TRIAL TO STUDY THE METABOLIC SIDE EFFECTS OF TWO DRUGS,BLONANSERIN IN COMPARISON WITH AMISULPRIDE, IN PERSONS WITH PSYCHOSIS.

A RANDOMISED, OPEN-LABEL CLINICAL TRIAL TO ASSESS CERTAIN METABOLIC SIDE EFFECTS OF NOVEL ATYPICAL ANTIPSYCHOTICS - BLONANSERIN IN COMPARISON WITH AMISULPRIDE,IN PERSONS WITH PSYCHOSIS.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003214
Enrollment
56
Registered
2012-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- PSYCHOSIS

Interventions

Intervention1: BLONANSERIN: 4MG TABLETS BD: BLONANSERIN 4MG TABLETS WILL BE GIVEN ORALLY WITH FOOD TWO TIMES A DAY (MORNING AND NIGHT) FOR 8 WEEKS DURATION. Control Intervention1: AMISULPRIDE: 200MG

Sponsors

MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Lead Sponsor
Dr BM PARASHIVAMURTHY
Collaborator
Dr RAVEESH BN
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: •Age between 18 - 60 years. •Both sexes. •Subjects with recent onset of psychotic symptoms and those with past history of psychotic symptoms having recurrence of psychotic symptoms currently. •Subjects who give informed consent.

Exclusion criteria

Exclusion criteria: •Subjects with suicidal tendencies. •Subjects having diabetes mellitus and abnormal lipid profile. •Acute infections or any serious concurrent illness. •Presence of organic brain syndrome (delirium, dementia). •Presence of alcohol and substance abuse/dependence, epilepsy, mental retardation, pregnancy and lactation. •Subjects who are on or who have received other antipsychotics in the last year. •Non complying subjects who are unable to give consent for the study

Design outcomes

Primary

MeasureTime frame
A)ANTHROPOMETRY - WEIGHT, BMI (BODY MASS INDEX) AND WAIST HIP RATIO. B)BLOOD INVESTIGATIONS - BLOOD SUGAR LEVELS (FBS, PPBS) AND LIPID PROFILE. Timepoint: DONE AT 4 WEEKS AND 8 WEEKS.

Secondary

MeasureTime frame
ADVERSE DRUG REACTIONS, MEDICATION COMPLIANCETimepoint: DONE AT BASELINE(BEFORE STARTING THE DRUG), 4WEEKS AND 8 WEEKS.

Countries

India

Contacts

Public ContactDr DEEPAK TS

MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE

raveesh6@yahoo.com9980138016

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026